IB COMMUNICATIONS PRESS RELEASES

Mulhouse, France, December 13, 2023 – CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, announces the development of a new potency assay to guide clinical development of CD34+ cell-based therapies for use in the pivotal Phase 3 trial for its lead indication, post-acute myocardial infarction. Data from the assay, published in Scientific Reports, demonstrates the potency of ProtheraCytes® clinical batches, and may improve development of additional therapies made from CD34+ cells, including CellProthera’s new program for ischemic stroke[i].

The funds will be used towards its Phase 3 clinical trial of its lead therapy arsenic trioxide as a 1st-line treatment of chronic Graft-versus-Host Disease (cGvHD). Given the current European funding situation, BioSenic has been creative in its financing strategy........

Lakewood, Colorado, US, December 7, 2023 – Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, is pleased to participate in the second Connecting the Dots series. The film series is produced for MedTech Europe member companies and highlights medical devices and their role in improving the healthcare landscape, elevating our quality of life and guiding the path toward a healthier future for the global population.

Mont-Saint-Guibert, Belgium, December 6, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, and its subsidiary Medsenic SAS, today announces that it has signed a term sheet with Singapore based fund TrialCap Pte. Ltd. (the "Term Sheet") and/or other lenders (the "Lender") for a proposed debt and equity financing.

Mulhouse, France, November 30, 2023 – CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, today announces that preclinical data supporting an expansion of its clinical pipeline, utilizing the company’s cell therapy platform for the treatment of ischemic stroke, has been published. The study, completed in conjunction with University of South Florida (USF) professor Cesar Borlongan, Ph.D., adds to the growing body of evidence showing the potential of expanded CD34+ stem cells to regenerate damaged tissue in multiple ischemic diseases.

Bristol, UK, November 16, 2023 – eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, announced the hiring of Matthew Paterson as the company’s first Chief Commercial Officer, to spearhead the company’s growth and international footprint as it expands its contract development and manufacturing services for CGTs. Paterson joins from Quotient Sciences, where he built and led the North American business development team, creating and executing the global marketing and brand strategy. Over 18 years at Quotient, he held a number of senior leadership positions and most recently served as VP of Corporate Strategy.

Mataró, Barcelona, Spain, November 16, 2023 - Minoryx Therapeutics, a registration stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces the first patients have been enrolled in its US Phase 3 clinical trial (CALYX) of lead candidate leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD), an orphan indication with no alternative therapeutic options. 

Mont-Saint-Guibert, Belgium, October 25, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the innovative company addressing unmet medical needs in the areas of innate immunity, inflammation and organ/function repair, today provides its business update for the third quarter, ended September 30, 2023.

Cardiff, UK, October 11, 2023 – TrakCel, the leading and proven provider of cellular orchestration systems to the global cell and gene therapy (CGT) industry, today announces the re-appointment of one of its co-founders, Dr. Akshay Peer, as Senior Vice President Product. Dr. Peer returns to TrakCel from Bluecrux, having gained nearly three years of insight into the challenges facing the CGT industry, specifically solutions designed to refine the scheduling of manufacturing capacity. This experience will be critical as the industry continues to position to meet growing commercial demand. 

Bristol, UK, October 11, 2023 – eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, today launches its new Cell and Gene Therapy Centre GMP facility, to support the simultaneous production of multiple therapies for clinical trials. The cutting-edge, 65,000 sq ft facility – designed with the same extensive knowhow eXmoor has used to advise manufacturers for decades – offers much-needed capacity and capability to help scale the next generation of CGTs for human trials and beyond. The facility is the final step in eXmoor’s expansion into a full-service CGT contract development and manufacturing organization (CDMO).

Miami, Florida, US, October 9, 2023 - OrganaBio, the Contract Technology Development and Manufacturing Organization (CTDMO) specializing in solutions for cell and immunotherapy development, today announces the official launch of Cell Processing and Cryopreservation (CPC) Services, a new division of OrganaBio. CPC Services has been specifically developed to provide decentralized clinical trial support, including timely sample processing and data capture that are essential to accurately gauge the outcomes of clinical trials.

Mont-Saint-Guibert, Belgium, October 5, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the innovative company addressing unmet medical needs in in the areas of innate immunity, inflammation and organ/function repair, today announces an increase in the total number of voting rights and shares as a result of the issuance of new shares following the conversion of convertible bonds. The following information is published in accordance with article 15 of the Belgian law of 2 May 2007 on the publication of major shareholdings in issuers whose shares are admitted to trading on regulated market.

Lakewood, Colorado, October 5, 2023 – Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, and BioCentriq, a clinical-phase Cell Therapy CDMO (contract development and manufacturing organization), announced the next phase of their collaboration working to demonstrate the capabilities of Terumo BCT’s automated cell and gene therapy platforms to accelerate CAR-T cell development. On the heels of BioCentriq’s LEAP (TM) Advanced Therapy Platform launch in June, the companies aim to generate and publish the first publicly available data on rapid CAR-T cell manufacturing using Terumo BCT’s Quantum Flex and Finia platforms. The study is designed to show how quickly a cell therapy company can generate large volumes of high-quality CAR-T cells. The workflow being developed is lower in complexity and rapidly GMP-translatable owing to the synergies between Terumo BCT’s technology and process expertise supplied by BioCentriq.

St. Paul, MN and Houston, TX, US, October 4, 2023 — ScaleReady, the cell therapy manufacturing solutions expert, and CTMC, a joint venture between National Resilience Inc. and MD Anderson Cancer Center, today announces a collaborative partnership to help lessen the manufacturing barriers holding back life-saving cell and gene therapies from reaching more patients by integrating cutting-edge automation tools. The agreement will enable CTMC to strategically scale the recently completed GMP facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo(R) and Cue(R) cell processing systems.

Sydney, Australia, October 3, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today announces an abstract has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2023, taking place in San Diego, California and virtually from November 1 to 5 , 2023.

Lakewood, Colorado, US and Rome, Italy – September 21, 2023 – Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, and MCQ Instruments, a leading manufacturer of fully automated gas mixers, announced a collaboration to increase flexibility for cell therapy production by offering the Quantum Flex Cell Expansion System with the MCQ Nano 3. By accessing the platforms together, makers of advanced therapies now have an alternative for manufacturing spaces that cannot accommodate pre-mixed gas tanks.

Sydney, Australia, September 21, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the regulatory authorization of eftilagimod alpha (“efti”) manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including Germany, Belgium, Denmark, and the United Kingdom.

Mulhouse, France, September 20, 2023 – CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, today announces the last patient has enrolled and been treated in its EXCELLENT phase I/IIb clinical trial for its ProtheraCytes(R) autologous cell therapy, intended to prevent heart failure in patients following severe acute myocardial infarction (AMI). With this milestone, CellProthera remains on track for a full readout from the EXCELLENT (Expanded Cell Endocardiac Transplantation) trial by the first half of next year.

LAKEWOOD, Colorado, US, September 19 2023 – Terumo Blood and Cell Technologies, a medical technology company, today announces that Jackie Kunzler is the newly appointed Senior Vice President, Research and Development (R&D). She will serve on the Executive Management Committee.

Mont-Saint-Guibert, Belgium, September 19, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal. 

Mont-Saint-Guibert, Belgium, 7 September 2023 – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today publishes its business update for the first half, ended 30 June 2023, prepared in accordance with IFRS as adopted by the European Union, and the outlook for the remainder of the year. 

Quantum technology optimized for automated expansion of cell and gene therapy components.
LAKEWOOD, Colorado, US, September 7 2023 – Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, announced the publication of a peer-reviewed manuscript regarding a new protocol for automated expansion of HEK293T cells that are used to produce the viral vectors powering cell and gene therapies. The accepted manuscript, published today in Biology Methods & Protocols, demonstrates the flexibility of Terumo BCT’s hollow-fiber bioreactor systems for expanding a variety of cells with therapeutic relevance and offers guidance to advanced therapeutics developers and contract manufacturers looking to improve the efficiency of vector and cell production.

Germantown, Maryland – September 6, 2023 – Orgenesis, a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), continues to grow the infrastructure of the advanced therapeutic POCare services and facilities supply business, Octomera. The appointment of Gerhard Bauer as the Vice President of Global Product Implementation at Octomera has been made to enhance the existing process development, regulatory, engineering, equipment, and data/technical service offering and POCare Center hubs. He is also an active contributor to the evolution of the flexible facilities format, Octomera Mobile Process Labs & Units (OMPULs) and network, which allow the traditional facility build time to be cut down from years to under six months.

Mont-Saint-Guibert, Belgium, September 1 2023,– BIOSENIC, the innovative company addressing unmet medical needs in in the areas of innate immunity, inflammation and organ/function repair, today announces an increase in the total number of voting rights and shares as a result of the issuance of new shares following the conversion of convertible bonds. The following information is published in accordance with article 15 of the Belgian law of 2 May 2007 on the publication of major shareholdings in issuers whose shares are admitted to trading on regulated market.

Mont-Saint-Guibert, Belgium, August 24 , 2023 – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces the issuance of a key new patent entitled ‘Use of metal ions to potentiate the therapeutic effects of arsenic’ to its subsidiary company Medsenic by the China National Intellectual Property Administration (CNIPA). This patent (ZL202080040613.1) covers the use of its ATO platform in combination with metal ions like copper, which has the potential to improve the treatment of autoimmune diseases. The European Patent Office (EPO) granted similar protection (EP3972613) in April 2023.

Bristol, UK and Gainesville, Florida, August 23, 2023 – eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, and Kincell Bio, a contract development and manufacturing organization (CDMO) focused on cell therapies, today announced the formation of a new global partnership for a breadth of advanced therapy manufacturing services. This partnership seamlessly brings together both companies’ CGT manufacturing capabilities in Europe and the US. Customers can now access a global development and manufacturing footprint in combination with the boutique customer-focused offerings of both companies.

Germantown, MD, US, August 11, 2023 - Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today provided a business update for the second quarter ended June 30, 2023.

LAKEWOOD, Colorado, US, August 1, 2023 – Terumo Blood and Cell Technologies (Terumo BCT) announces US Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing System, the first whole blood automation device available in the US that processes whole blood into platelets and other components in a single centrifugation cycle. Automated processing of whole blood on the Reveos system, the only device of its kind globally, will enhance the blood and platelet supply for patients in the US.

Sydney, Australia, August 1, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the continued development of eftilagimod alpha (efti), the Company's soluble LAG-3 protein and first-in-class MHC Class II agonist.

SYDNEY, AUSTRALIA, July 31, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for its fiscal fourth quarter ended 30 June 2023 (Q4 FY23).

Sydney, Australia, July 28, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the first patient has been enrolled and safely dosed in EFTISARC-NEO, the Phase II investigator-initiated trial of eftilagimod alpha (efti), a soluble LAG-3 protein and MHC Class II agonist, in combination with radiotherapy and the anti-PD-1 therapy KEYTRUDA(R) (pembrolizumab) for patients with soft tissue sarcoma. This chemo-free trial is the first to evaluate efti in a neoadjuvant setting.

Germantown, Maryland, July 11, 2023 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, today announced the name change of the POC Services business from Morgenesis to Octomera, effective June 30, 2023, to reflect the growth and focus on providing advanced cell and gene therapy (CGT) services, facilities, and technologies. Morgenesis was originally formed in 2022 to separate Orgenesis’ existing POCare Service and supply solutions from the other operations of Orgenesis. A new Octomera website and rebranding will be unveiled throughout the second half of 2023.

Mont-Saint-Guibert, Belgium, July 10, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the innovative company addressing unmet medical needs in the areas of innate immunity, inflammation and organ/function repair, today announces a further update on its financial arrangements with its main historical creditors, Patronale, Monument and the European Investment Bank. BioSenic aims at renegotiating its main financial debts, inherited from Bone Therapeutics. This is required for BioSenic to successfully launch a new fundraising, in the form of a private placement in Q3-4 2023. 

Birmingham, UK, July 10, 2023 - UK immersive technology company FourPlus, along with collaborators Holosphere and the Cell and Gene Therapy Catapult, have been awarded funding from Innovate UK to create and test a mixed-reality training platform that enables customized training delivery for pharmaceutical companies and healthcare.

Mont-Saint-Guibert, Belgium, June 30, 2023 – BIOSENIC (Euronext Brussels and Paris: BIOS), the innovative company addressing unmet medical needs in the areas of innate immunity, inflammation and organ/function repair, today provides a financial update.

Sydney, Australia, June 28, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, today announces the successful completion of an AUD 80 million capital raise to support its late-stage and expanding clinical development pipeline. With this new capital, Immutep believes it is fully funded for its current and expanded clinical program through to Q1 CY2026 with a pro-forma cash balance of AUD 135.2 million (USD 90.6 million).[1]

Sydney, Australia, June 21, 2023 - Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced the grant of a new patent (number 11,680,104) by the United States Patent Office. The granted claims are composition-of-matter type claims covering Immutep’s pre-clinical immunosuppressive product candidate IMP761, a first-in-class agonist LAG-3 antibody designed to target the root cause of autoimmune diseases by directly silencing self-antigen-specific effector T cells.

Mont-Saint-Guibert, Belgium, June 20, 2023 – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell repair, will present the latest data on its arsenic trioxide (ATO) platform at the 25th International Conference on Redox Medicine 2023, held by Redox Medicine Society on June 21-23 in Paris, France. “Arsenic-Copper: A Double-Edged Sword for a Unique Double Benefit against Immunological Disorders”, will be presented by Dr. Carole Nicco, Chief Scientific Officer at BioSenic and newly elected President of Redox Medicine Society.

Mont-Saint-Guibert, Belgium, June 19 2023 – BioSenic (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune and inflammatory diseases and bone and cartilage cell repair, today announces the decision to suspend its interventional trial on fracture healing, using the ex-Bone-Therapeutics lead product, ALLOB. This decision follows negative results obtained for the primary endpoint in the exploratory Phase IIb trial (ALLOB IIb), which focused on safety and treatment timing efficacy.

Prague, Czech Republic and Vienna, Austria, June 15, 2023 – SCTbio, a full-service contract development and manufacturing organization (CDMO) specializing in cell-based therapy and viral vectors, and Cyto-care.eu GmbH, a company that specializes in providing advanced solutions for cell therapy and regenerative medicine, have signed a collaboration agreement to improve the quality of cryopreservation for cell therapy development in Europe. The goal of the collaboration is to address the critical need for efficient collection, cryopreservation, quality control and logistics capabilities of leukapheresis materials to support various aspects of the cell therapy workflow.

Germantown, Maryland and Davis, California, US, June 7, 2023 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, and University of California, Davis (UC Davis), today announce an agreement to roll out proprietary Orgenesis Mobile Processing Units and Labs(TM) (“OMPULs(TM)”) at medical or academic institutions within the University of California system. The partnership agreement sets out a staged approach through which Orgenesis will install and operate OMPULs(TM), enabling their proprietary point-of-care (“POCare”) Service Platform to manufacture therapeutics at hospitals throughout California, empowering onsite production for clinical trials like the cell and gene therapies in development at UC Davis Health’s Alpha Stem Cell Clinic.

Sydney, Australia, June 5, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today provides an overview of the positive final data from Part C of the TACTI-002 Phase II trial to be presented in a poster presentation at the ASCO 2023 Annual Meeting taking place in Chicago, US.

Mont-Saint-Guibert, Belgium, June 1, 2023, – BIOSENIC (Euronext Brussels and Paris: BIOS), the innovative company addressing unmet medical needs in in the areas of innate immunity, inflammation and organ/function repair, today announces an increase in the total number of voting rights and shares as a result of the issuance of new shares following the conversion of convertible bonds (CBs). The following information is published in accordance with Article 15 of the Belgian Law of 2 May 2007 on the publication of major shareholdings in issuers whose shares are admitted to trading on regulated market.